Planning and Execution

Japan presents some unique challenges and complexities when it comes to the management of both clinical trial and marketed product pharmacovigilance (PV). The Japan Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) have safety reporting requirements that differ significantly from EU and US standards. This article will discuss the key considerations for developing a PV group in Japan that includes the right procedures, timelines, and systems, but, most of all, the right team.

Individual Case Safety Report (ICSR) Processing

The enforcement regulations of the Pharmaceutical and Medical Device Act stipulates the provisions of reporting ICSRs, as indicated in Tables 1-4. A key difference from EU and US standards is the PMDA requirement to report measures taken overseas for medicinal products containing the same API and research reports. Measures taken overseas require review of regulatory authority websites to identify any ICSRs that meet the criteria (see Table 3). Typically, the process of searching these websites is subcontracted to a local vendor, which provides a daily email of potential measures taken overseas with the PV team reviewing these outputs to confirm whether the criteria has been met. Research reports involve searching both local and global scientific literature databases based on preagreed search strings and then reviewing the outputs to identify any ICSRs that meet the criteria (see Table 4, page 29).

Additionally, reporting certain adverse drug reactions (ADRs) assessed as expected against the current reference safety information (RSI) is needed; this is also a departure from EU and US standards.

Gary Barker joined PPD’s PV department in 2005 and has spent time in Singapore and Australia developing the company’s capabilities in Asia-Pacific. He is accountable for clinical trial and marketed product PV across Asia-Pacific Eastern Europe and projects in North America.

April Pierce joined PPD in 2000 and has served the majority of her tenure in operational management of global projects. Currently, her primary role is providing oversight of the PV strategic proposal development group for both clinical trials/ marketed projects and managing PV’s budget operational staff.

Dr Yasmine Chiu joined PPD in 2012 and is a member of the company’s medical monitor senior management team. She is responsible for medical monitoring oversight for clinical trials across Asia-Pacific, including Japan and China.

Yasumasa Kurioka joined PPD-SNBL as General Manager in 2015. He is responsible for all clinical functions at PPD-SNBL in Japan. He has more than 25 years of experience with both CRO and pharma companies.

Tsutomu Yonehana joined the PPD-SNBL PV department in 2018. He has worked in PV roles of responsibility for 20 years. Most recently, he served as Senior Safety Manager at Celgene Japan where he was responsible for the oversight of all PV activities for sponsored clinical trial and marketed product programmes.

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